NCT04187118

Brief Summary

Malignant lymphomas are considered as among the most chemo-sensitive cancers. ML are cured in more than 85% of patient, the majority with complete response. After this active phase of treatment, patients are in "after cancer period". Toulouse University Hospital developed since 2006 the Ambulatory Medical Assistance for After Cancer program on lymphoma patient. Ambulatory Medical Assistance for After Cancer is very efficient for detecting physical and psychological complications which impact quality of life. The investigators identified 22% of lymphoma patients who had a reduced quality of life one year after the end of chemotherapy. The present study aims to investigate the evolution of observed complications and identify cancer care pathway which decrease the quality of life reduction risk in patients one year after lymphoma chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 28, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

5.3 years

First QC Date

November 27, 2019

Last Update Submit

September 18, 2023

Conditions

Keywords

LymphomaQuality Of LifeCancer Care PathwayPost-Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Quality of life change: Quality of Life-C30 French version

    Health-related quality of life is evaluated by the use of Quality of Life-C30 French version

    Change from baseline quality of life at 12 month

Study Arms (1)

Lymphoma patients

Patients being in complete response after a first therapy for malignant lymphoma.

Other: Quality of life

Interventions

Quality of life one year post chemo-therapy

Lymphoma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lymphoma

You may qualify if:

  • Patients being in complete response after a first therapy for lymphoma
  • Malignant lymphoma (Hodgkin or non-Hodgkin) treated by anthracyclines with a minimum of 6 cycles, followed or not by autologous hematopoietic stem cell transplantation
  • Patients informed of the study and not opposed to the research

You may not qualify if:

  • Patients under legal guardian .
  • Patients unavailable to formulate non-opposition to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Loïc YSEBAERT, MD, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Loïc YSEBAERT, MD, PhD

CONTACT

Fabien DESPAS, Pharm, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 5, 2019

Study Start

January 28, 2020

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations